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The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M, J-STARS collaborato - EBioMedicine (2015)

Bottom Line: No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan.After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

ABSTRACT

Background: Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.

Methods: This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.

Finding: Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.

Interpretation: Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.

Funding: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

No MeSH data available.


Related in: MedlinePlus

Cox proportional hazards for stroke and TIA (S1), atherothrombotic infarction (S2), lacunar infarction (S3), and intracranial hemorrhage (S4) in pre-defined subgroups. Bars represent the relative risk with a 95%CI. p values for interaction test for heterogeneity of treatment across subgroups. *Hazard ratio was not obtained because of low number of subjects and events. TIA, transient ischemic attack. HDL, high density lipoprotein. LDL, low density lipoprotein. SBP, systolic blood pressure. DBP, diastolic blood pressure. ACA, anterior cerebral artery. MCA, middle cerebral artery. PCA, posterior cerebral artery. VA, vertebral artery. BA, basilar artery. mRS, modified Rankin scale. CDR, clinical dementia rating.
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f0030: Cox proportional hazards for stroke and TIA (S1), atherothrombotic infarction (S2), lacunar infarction (S3), and intracranial hemorrhage (S4) in pre-defined subgroups. Bars represent the relative risk with a 95%CI. p values for interaction test for heterogeneity of treatment across subgroups. *Hazard ratio was not obtained because of low number of subjects and events. TIA, transient ischemic attack. HDL, high density lipoprotein. LDL, low density lipoprotein. SBP, systolic blood pressure. DBP, diastolic blood pressure. ACA, anterior cerebral artery. MCA, middle cerebral artery. PCA, posterior cerebral artery. VA, vertebral artery. BA, basilar artery. mRS, modified Rankin scale. CDR, clinical dementia rating.

Mentions: As the primary endpoint, total stroke and TIA similarly occurred in pravastatin and control group (2.56 vs. 2.65%/year, p = 0.82, adjusted HR 0.97 [95%CI 0.73 to 1.29], Fig. 3A), and the finding was virtually unaffected when TIA was excluded from the analysis (2.35 vs. 2.47%/year, p = 0.74, adjusted hazard ratio 0.95 [95%CI 0.71 to 1.28]). However, occurrence of atherothrombotic infarction was less frequent in the pravastatin group (0.21 vs. 0.65%/year, p = 0.0047, adjusted HR 0.33 [95%CI 0.15 to 0.74], Fig. 3B). Additionally, such trend was present in patients both with atherothrombotic and lacunar infarction at baseline (Appendix Table 2), and appeared to exist in certain subgroups of patients (Appendix Fig. 2). Occurrence of lacunar infarction (Fig. 3C), cardioembolic infarction (Fig. 3D), and intracranial hemorrhage (Fig. 3E) was similar between the two groups, so was the occurrence of myocardial infarction, vascular accidents, death, and hospitalization (Table 2).


The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M, J-STARS collaborato - EBioMedicine (2015)

Cox proportional hazards for stroke and TIA (S1), atherothrombotic infarction (S2), lacunar infarction (S3), and intracranial hemorrhage (S4) in pre-defined subgroups. Bars represent the relative risk with a 95%CI. p values for interaction test for heterogeneity of treatment across subgroups. *Hazard ratio was not obtained because of low number of subjects and events. TIA, transient ischemic attack. HDL, high density lipoprotein. LDL, low density lipoprotein. SBP, systolic blood pressure. DBP, diastolic blood pressure. ACA, anterior cerebral artery. MCA, middle cerebral artery. PCA, posterior cerebral artery. VA, vertebral artery. BA, basilar artery. mRS, modified Rankin scale. CDR, clinical dementia rating.
© Copyright Policy - CC BY
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4588424&req=5

f0030: Cox proportional hazards for stroke and TIA (S1), atherothrombotic infarction (S2), lacunar infarction (S3), and intracranial hemorrhage (S4) in pre-defined subgroups. Bars represent the relative risk with a 95%CI. p values for interaction test for heterogeneity of treatment across subgroups. *Hazard ratio was not obtained because of low number of subjects and events. TIA, transient ischemic attack. HDL, high density lipoprotein. LDL, low density lipoprotein. SBP, systolic blood pressure. DBP, diastolic blood pressure. ACA, anterior cerebral artery. MCA, middle cerebral artery. PCA, posterior cerebral artery. VA, vertebral artery. BA, basilar artery. mRS, modified Rankin scale. CDR, clinical dementia rating.
Mentions: As the primary endpoint, total stroke and TIA similarly occurred in pravastatin and control group (2.56 vs. 2.65%/year, p = 0.82, adjusted HR 0.97 [95%CI 0.73 to 1.29], Fig. 3A), and the finding was virtually unaffected when TIA was excluded from the analysis (2.35 vs. 2.47%/year, p = 0.74, adjusted hazard ratio 0.95 [95%CI 0.71 to 1.28]). However, occurrence of atherothrombotic infarction was less frequent in the pravastatin group (0.21 vs. 0.65%/year, p = 0.0047, adjusted HR 0.33 [95%CI 0.15 to 0.74], Fig. 3B). Additionally, such trend was present in patients both with atherothrombotic and lacunar infarction at baseline (Appendix Table 2), and appeared to exist in certain subgroups of patients (Appendix Fig. 2). Occurrence of lacunar infarction (Fig. 3C), cardioembolic infarction (Fig. 3D), and intracranial hemorrhage (Fig. 3E) was similar between the two groups, so was the occurrence of myocardial infarction, vascular accidents, death, and hospitalization (Table 2).

Bottom Line: No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan.After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

ABSTRACT

Background: Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.

Methods: This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.

Finding: Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.

Interpretation: Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.

Funding: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

No MeSH data available.


Related in: MedlinePlus